The object of the present invention is a new pharmaceutical preparation containing phospholipids for the therapeutic treatment of rheumatic diseases.
A large number of nonsteroidal antirheumatics are used in the treatment of rheumatic diseases. One of the most frequently applied groups of substances are the oxicams, such as for example piroxicam. Rheumatism therapy is usually long term. Medicines, the therapeutic application whereof as a rule is necessary over an extended period of time, must satisfy specific requirements in relation to their therapeutic breadth. As a consequence of the daily intake of such medicines, high stresses on the gastrointestinal tract as the absorption location, on the liver as the preferred bioconversion organ, and the elimination tracts, are unavoidable.
It is known that in the course of extended treatments with oxicams for example gastrointestinal disorders, including hemorrhaging, hemotopesis, disorders, headaches, vertigo, damage to the liver and kidneys, and edemas may occur. The most frequent side effects are gastrointestinal disturbances. Oxicams are metabolized or eliminated through the liver and the kidneys. This, however, may lead in particular in the case of patients with restricted liver or renal functions to considerable side effects. In patients with preexisting liver function disorders increased caution is required as the reduced bioconversion increases the danger of possible side effects. Thus, for example it was necessary to withdraw sudoxicam (4-hydroxy-2-methyl-N-(2-thiazolyl)2H-1,2-benzthiazine-3-carboxyamide-1,1- dioxide) from clinical testing because of considerable liver toxicity (Side Effects of Drugs, Annual 6; Excerpta Medica 1982, p. 103). DE-PS No. 28 56 333 discloses an improvement of the gastointestinal tolerance of nonsteroidal antiphlogistics by the addition of phospholipids, wherein the molar ratio of the active ingredient to the phospholipid may amount to up to 1:20.
It is the object of the present invention to provide a pharmaceutical preparation for the treatment of rheumatic diseases containing as the specific active ingredient oxicam derivatives and exhibiting increased tolerance in particular with respect to the liver, without altering the inflammation inhibiting effect of the oxicams.